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ASSAf Panel: Regulatory Implications of
New Genetic Engineering Technologies
Jasper Rees
Agricultural Research Council, So...
Why address new GE technologies now?
Application
stage
No. of Countries
Commercial
production
3
Confined field
testing
7
C...
GM Crop R&D in Africa
Application stage No. of Countries Country Names
Commercial
production
3 Burkina Faso; Egypt; South ...
Why an panel now?
• DAFF and DEA represented at workshop to
launch JRC report in 2011
• 2012 DST aware of JRC report
• Pre...
Applying scientific thinking
in the service of society
Regulatory Implications of New Genetic
Engineering Technologies:
Co...
Applying scientific thinking
in the service of society
Brief Overview on Consensus Studies
Consensus Studies
Purpose:
• To provide credible, independent and unbiased evidence-
based policy recommendations that are...
Consensus Studies
Key Requirements:
• Well-defined set of key questions or problems;
• Knowledgeable and balanced panel of...
Consensus Studies
Panel meetings:
• All study panel deliberations are confidential – it enables
the panel to develop draft...
Consensus Studies
Information Gathering Processes:
• The study panel typically gathers information through:
 reviewing of...
Consensus Studies
Drafting of the Report:
• Panellists often draft the different chapters or portions of the
report but th...
Mandate and ToR
• 1) Evaluate the risk/benefit implications and ethics of all relevant
new technologies (generally, but al...
Who is who?
• Dr Hennie Groenwald – CEO Biosafety SA
• Prof Gustav Bouwer – Wits University – Chair of GMO
EC
• Dr Kingsto...
Target technologies – including:
• Cis-genesis and intragenesis
• MegaNucleases (ZFN, TALEN, CRISPR)
• Oligo directed muta...
Possible outcomes
• Leave the GM Act and Regulations as they are.
• Recommend minor changes to the Regulations
to cover th...
Dr Jasper Rees
ReesJ@arc.agric.za
New Traits being released
• Innate™ potato, a food staple with lower
levels of acrylamide, a potential carcinogen,
and les...
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ASSAf Panel: Regulatory implications of new genetic engineering technologies

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Presented by Jasper Rees, Agricultural Research Council, South Africa, at the Workshop on Animal Genetic Research for Africa (Biosciences for Farming in Africa), Nairobi, 10-11 September 2015

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ASSAf Panel: Regulatory implications of new genetic engineering technologies

  1. 1. ASSAf Panel: Regulatory Implications of New Genetic Engineering Technologies Jasper Rees Agricultural Research Council, South Africa Animal Genetic Research for Africa (Biosciences for Farming in Africa), Nairobi, 10-11 September 2015
  2. 2. Why address new GE technologies now? Application stage No. of Countries Commercial production 3 Confined field testing 7 Contained research At least 14 Developing capacity for research and development At least 27
  3. 3. GM Crop R&D in Africa Application stage No. of Countries Country Names Commercial production 3 Burkina Faso; Egypt; South Africa Confined field testing 7 Burkina Faso; Egypt; Kenya; South Africa; Uganda; Nigeria; Malawi Contained research At least 14 Burkina Faso; Cameroon; Egypt; Ghana; Kenya; Mali; Mauritius; Namibia; Nigeria; South Africa; Tanzania; Tunisia; Uganda; Zimbabwe; Malawi Developing capacity for research and development At least 27 South Africa; Burkina Faso; Egypt; Kenya; Morocco; Senegal; Tanzania; Uganda; Zambia; Zimbabwe; Benin; Cameroon; Ghana; Malawi; Mali; Mauritius; Namibia; Niger; Nigeria; Tunisia; Algeria; Botswana; Ethiopia; Madagascar; Rwanda, Burundi, Sudan
  4. 4. Why an panel now? • DAFF and DEA represented at workshop to launch JRC report in 2011 • 2012 DST aware of JRC report • Presentation on NPBT to GMO Exec Council - 2013 • DST plans process to assess NBPT • 2014 – DST Commissions AASAf study to ensure independent process • 2015 – ASSAf Panel convenes and starts work
  5. 5. Applying scientific thinking in the service of society Regulatory Implications of New Genetic Engineering Technologies: Consensus Study Panel 2015-16 5
  6. 6. Applying scientific thinking in the service of society Brief Overview on Consensus Studies
  7. 7. Consensus Studies Purpose: • To provide credible, independent and unbiased evidence- based policy recommendations that are based on consensus reached through study panel deliberations. Processes – broadly divided into five categories: 1. Development of the the Study Brief (Proposal) 2. Selection of the Study Panel & Council Approval 3. Panel Meetings, Information Gathering & Drafting of the Report 4. Peer-Review Process, Finalization & Approval of the Report 5. Release & Dissemination of the Report
  8. 8. Consensus Studies Key Requirements: • Well-defined set of key questions or problems; • Knowledgeable and balanced panel of experts; • Opportunities for the panel to gather information in public and to deliberate in private in order to reach consensus; • Unbiased evidence-based analysis by the panel - free from the influence of study sponsors or others with a vested interest in the outcome of the study findings; • Production of a consensus output expressed as findings, conclusions & recommendations in publicly released statements, reports or advisory documents.
  9. 9. Consensus Studies Panel meetings: • All study panel deliberations are confidential – it enables the panel to develop draft findings and recommendations free from outside influence; • Summaries of particular discussions may, at the discretion of the Chair, be prepared and released for public comment and/or the gathering of further information and evidence; • Certain activities of Study Panels may take the form of public conferences, workshops, debates and hearings (from which the Study Panel will then confidentially draw its conclusions).
  10. 10. Consensus Studies Information Gathering Processes: • The study panel typically gathers information through:  reviewing of existing scientific literature,  investigations conducted by the panel members and staff,  commissioning/contracting experts/researchers,  meetings/workshops open to the public & announced in advance, and  submission of information by outside parties. • Sponsors can be invited to present to the panel in order to discuss their expectations and they are also asked to provide as much information relevant to the study as possible.
  11. 11. Consensus Studies Drafting of the Report: • Panellists often draft the different chapters or portions of the report but the final report is a collective product of the panel;  Authorship is for the whole panel & final report becomes ASSAf property. • The Consensus Study Panels take full responsibility for the draft reports prepared by them; • The Study Panel Chair (or, where absolutely essential, the Chair’s nominee) is the only spokesperson until the public release of the report after ASSAf Council approval; • Thereafter, the ASSAf President becomes the spokesperson; • The Panel issues a single final ASSAf Report that is in line with its approved study brief.
  12. 12. Mandate and ToR • 1) Evaluate the risk/benefit implications and ethics of all relevant new technologies (generally, but also with specific reference to their ability to sustain the diversity of agricultural crops, their ability to improve the agronomy, production and/or value of the crops). • 2) Determine – with justification - which new technologies should fall under the GMO Act and which do not. • 3) Outline a framework which can be used to assess the applicability of future technologies to the existing GMO Act & regulations. • 4) Assess the appropriateness of South African biosafety regulatory framework for biosafety risk evaluation and management of all relevant new technologies. • 5) Where appropriate, recommend modifications/revisions and/or additions to the existing regulations, individually or collectively, for the new technologies.
  13. 13. Who is who? • Dr Hennie Groenwald – CEO Biosafety SA • Prof Gustav Bouwer – Wits University – Chair of GMO EC • Dr Kingstone Maisingaidze – ARC – Lead maize breeder and ARC PI in WEME and IMAS • Dr Jasper Rees – ARC – GE RIS • Prof Inqbal Parker – Director of ICGEB Cape Town • Mr Kulani Machaba – SANSOR representative and Pioneer Regulatory Officer – withdrew in first meeting • Two more members to be added by ASSAf
  14. 14. Target technologies – including: • Cis-genesis and intragenesis • MegaNucleases (ZFN, TALEN, CRISPR) • Oligo directed mutagenesis • RNA dependent DNA methylation and epigenesis • Grafting onto GM rootstocks • Reverse Breeding • Agroinfiltration • Synthetic Biology • Rapid Breeding technologies • Gene Drives
  15. 15. Possible outcomes • Leave the GM Act and Regulations as they are. • Recommend minor changes to the Regulations to cover these technologies • Recommend changes to exclude some or all of these technologies from regulation • Recommend major review of GMO Act to address review and regulation of novel traits • Recommend ending all regulation…
  16. 16. Dr Jasper Rees ReesJ@arc.agric.za
  17. 17. New Traits being released • Innate™ potato, a food staple with lower levels of acrylamide, a potential carcinogen, and less wastage due to bruising • reduced lignin alfalfa event KK179 (HarvXtra™) with higher digestibility and yield • White maize, suger beet, brinjal…

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